A core feature of the Global Training Hub for Biomanufacturing (GTH-B) program is providing training and consulting services on-site at vaccine research institutes and manufacturing facilities in low- and middle-income countries. IVI conducted the first of these sessions with Incepta in Bangladesh last year followed by a second session with Afrigen Biologics & Vaccines (Afrigen) in South Africa. Led by subject experts from IVI, these trainings provide comprehensive overviews and practical applications of key aspects of biomanufacturing, including the production of vaccines and therapeutics.

In May and June of this year, a team of IVI trainers led sessions at the Kenya Medical Research Institute (KEMRI) and Kenya BioVax Institute in Nairobi as well as Institut Pasteur de Dakar (IPD) in Senegal. The trainings spanned the gamut of vaccine development production, including vaccine discovery and early clinical development, clinical trial design, aseptic processing, pharmaceutical quality systems, intellectual property and patent systems, vaccine process development, and technology transfer in addition to best practices in business development and project management.

The 3-day training held at KEMRI drew 55 professionals involved in vaccine development and production at KEMRI, BioVAX, and other organizations from Benin, Burundi, and Zambia. With a special focus on vaccine technology transfer—or the transfer of knowledge and processes from one organization to another to enable and increase production of vaccines—the training covered topics in standard operating procedures, documentation requirements, legal considerations, and real-life case studies.

As a new addition to the GTH-B on-site curriculum, the training included two dedicated sessions on project management, covering principles in how to manage discrete projects within phases of a vaccine clinical development program with step-by-step guidance for managing clinical trial schedules. The trainers shared the IVI method of project management, emphasizing that effective project management includes managing stakeholder relationships as well as risk and project governance.

Building capacity in technology transfer

The training included three sessions on technology transfer, covering every phase from planning and development to qualification and implementation.

What is a technology transfer and what are the general principles and goals of a successful one? How are Pharmaceutical Quality System regulations applied? Who are the stakeholders involved in a tech transfer and what are their roles? What are the phases and what kinds of qualifications are needed on the team?

These questions and more were addressed in the broad overview of what a technology transfer entails. To hone in on more specific aspects, the head of IVI’s Vaccine Process Development department, Dr. Gaurav Pandey, lectured on the proper documentation requirements and why they are critical to executing a credible transfer and meeting international regulations. Following, IVI’s IP & Legal Manager Megha Pansuriya explained the basics of intellectual property and the patent system, highlighting the legal aspects of transferring knowledge, process, and technologies between organizations while protecting IP and ensuring compliance.

Transferring vaccine technology and know-how is a sustainable channel for building up local and regional biomanufacturing capabilities. Through technology transfer, IVI helped bring the first low-cost oral cholera vaccine to the global public health market and is currently engaged in similar work for a typhoid conjugate vaccine and a dengue vaccine. Through the GTH-B on-site training program, IVI aims to increase knowledge of, and participation in, technology transfers with and among industry partners across Africa.

Find more information about the Global Training Hub for Biomanufacturing here. IVI thanks the Korean Ministry of Health and Welfare for supporting GTH-B.

by Aerie Em

Last updated June 23, 2023